PLAQUETTE D'IDENTIFICATION - Helmut Zepf
The Plaquette d'identification - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.312.07.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf identification plate (85.312.07)?
The Helmut Zepf identification plate, bearing the reference 85.312.07, is a logistical management accessory designed for the dental sector. Manufactured by Helmut Zepf Medizintechnik GmbH, it is structured in medical stainless steel, guaranteeing compatibility with repeated thermal reprocessing processes. This device is part of a dental instrument organization approach, allowing the marking and classification of various manual tools by practitioner, type of intervention, or treatment room. Its robust design ensures a durable hold within sterilization cassettes without altering the integrity of the instruments it accompanies.
What are the clinical indications for this device?
Although the plate itself is not a cutting or direct gripping instrument, its use is indicated in any oral surgery, implantology, or periodontology environment requiring rigorous management of the instrument park. It is used to identify sets of manual instruments during clinical and post-operative procedures. By facilitating dental instrument organization, it contributes to workflow safety by limiting handling errors or the mixing of devices between different phases of care and sterilization. It is strictly reserved for use by qualified healthcare professionals.
What are the technical characteristics of this plate?
This Class I medical device is characterized by its manufacture in high-quality medical stainless steel, in accordance with Helmut Zepf standards. Its technical reference 85.312.07 corresponds to a specific format adapted to the manufacturer's storage systems. The product is delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before its first use, as well as after each clinical use. Its design allows it to withstand steam sterilization cycles without notable degradation, although the user must check for the absence of visible damage such as cracks or defects before each integration into a technical tray.
What are the contraindications for the use of this equipment?
The main medical contraindication concerns hypersensitivity or known intolerance to metals, particularly stainless steel. If contact between the instrument and the patient triggers an allergic reaction, the procedure must be immediately interrupted and necessary clinical measures must be taken. Furthermore, it is formally contraindicated to use a plate showing visible signs of wear, breakage, or structural defects. The use of damaged products can compromise the hygiene of the technical tray or the sterilization process. Compatibility with other cleaning or organization products must also be verified beforehand by the practitioner.
What are the precautions related to reprocessing and maintenance?
Like any Helmut Zepf instrument, this identification plate requires a strict reprocessing protocol. Before the first commissioning, cleaning and sterilization are mandatory. Due to its stainless steel composition and simplified design, there is no defined maximum limit for treatment cycles, as long as the device does not show visible damage. The practitioner must regularly inspect the plate to detect any trace of corrosion or deformation. It is essential to respect standard sterilization parameters for steel devices to ensure the longevity of the dental instrument organization within the practice.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This product is classified as a Class I medical device (Class Ir according to certain reprocessing nomenclatures). It meets the regulatory requirements for manual stainless steel dental instruments. The manufacturer emphasizes that its products are intended exclusively for healthcare professionals and must be handled according to the safety and use instructions provided. Compliance with cleaning and sterilization protocols is crucial to maintain device conformity throughout its operational life.
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Specifications
| Manufacturer | Helmut Zepf |
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